A Study to Compare the Rate of Major Cardiovascular Implantable Electronic Device Infections with the Absorbable Antibacterial Envelope and without

Overview

  • Study type

    Interventional
  • Study phase

    IV
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 15-004798
    NCT ID: NCT02277990
    Sponsor Protocol Number: WRAP-IT

About this study

The purpose of this study is to evaluate the ability of the TYRX Absorbable Antibacterial Envelope to reduce major cardiovascular implantable electronic device infections through 12-months post-procedure following  generator replacement, upgrade, revision, or new CRT-D implant.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • Willing to sign and date the study patient informed consent form
  • At least 18 years of age and meets age requirements per local law
  • Planned to undergo at least one of the following
    • Has existing cardiovascular implantable electronic device and is undergoing IPG (including CRT-P), ICD or CRT-D replacement or upgrade with a new Medtronic generator is planned to have leads added, or extracted ,or upgrades can be enrolled 
    • Will undergo a new Medtronic CRT-D system implant per approved indications
    • had existing study eligible Medtronic CIED in which the pocket was not accessed within the last 365 days, and is undergoing pocket or lead revision
  • Willing to provide the contact information for the physician who provides followup for his/her CIED
  • Willing and able to comply with scheduled follow-up and study related activities

Exclusion Criteria:

  • Known allergy to minocycline or rifampin or their derivatives, or any other known contraindications to implantation of the TYRX envelope
  • Current therapy with chronic oral immunosuppressive agents or ≥ 20mg/day of Prednisone or equivalent
  • Hemodialysis or peritoneal dialysis
  • Prior Cardiac transplantation or existing Ventricular Assist Device (VAD)
  • Require long-term vascular access for any reason
  • Prior history of a CIED infection, other prosthetic device infection, or endovascular infection, including endocarditis, in the past 12 months
  • Physical, clinical, or laboratory signs or symptoms consistent with an active infection (including but not limited to pneumonia, urinary tract, cellulitis, or bacteremia)
  • Systemic lupus erythematous, because minocycline has been reported to aggravate this condition
  • Is pregnant, or of childbearing potential and not on a reliable form of birth control
    • Women of childbearing potential are required to have a negative pregnancy test within 7 days prior to device procedure
  • Participation in another study that may confound the results of this study
    • Coenrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic study manager

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Malini Madhavan, M.B.B.S.

Closed for enrollment

Contact information:

Malini Madhavan M.B.B.S.

Madhavan.Malini@mayo.edu